Catheter RF Perforation Device Positional Markers

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Solution Overview

Problem

Current methods for fluoro-less cardiac procedures lack effective positional cues, leading to potential misinterpretation and confusion during medical procedures, as simple solid markers provide limited information and may be perceived incorrectly by users.

Innovation Solution

A transseptal access and crossing system that includes an outer guide member and a radiofrequency perforation device with distal, intermediate, and proximal markers, which are positioned and sized to provide clear indications of the radiofrequency perforation device's location relative to the outer guide member, using contrasting colors and potentially tactile markers.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If fluoroscopic imaging is used to guide catheter positioning, then positioning accuracy is improved, but radiation exposure to the patient increases

Engineering Contradiction:
Improvepositioning accuracyVSAvoidradiation exposure
Core Design Contradiction:
Measurement precisionVSObject-affected harmful factors

Solution Approach 1:

The patent introduces markers as an intermediary visual aid that allows physicians to determine catheter position without relying on fluoroscopic imaging. The markers serve as a mediator between the catheter and the physician's visual assessment, enabling fluoro-less procedures while maintaining positioning accuracy

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The patent replaces the mechanical/radiological system of fluoroscopic imaging with a visual system using markers. Instead of using X-rays to visualize catheter position, the system uses optically visible markers that can be seen directly during the procedure, eliminating the need for continuous fluoroscopic exposure

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

2Device complexity

If simple solid markers are used on guidewires, then device complexity is reduced, but information clarity and user understanding deteriorate

Engineering Contradiction:
Improvemarker complexityVSAvoidpositioning information clarity
Core Design Contradiction:
Device complexityVSLoss of information

Solution Approach 1:

The patent divides the marker system into multiple distinct markers positioned at specific locations along the catheter (distal marker at the tip, intermediate marker at the radiopaque tip, proximal marker near the hub). Each marker serves a specific function and provides different positioning information, allowing physicians to determine catheter depth and orientation more accurately without excessive complexity

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The patent applies different marker characteristics at different locations along the catheter. The distal marker is positioned to indicate tip location, the intermediate marker indicates radiopaque tip position, and the proximal marker indicates hub proximity. Each marker has specific visual properties (color, size, shape) optimized for its local function, improving overall information clarity

Inventive Principle:
Principle #3Local quality

Data Source

PatentUS20250041021A1Positional markers for catheter wires
Publication Date: 2025.02.06 BOSTON SCI MEDICAL DEVICE LTD
  • US20250041021A1 patent drawing
  • US20250041021A1 patent drawing
  • US20250041021A1 patent drawing

AI summary

A transseptal access and crossing system for perforating a septum in a patient's heart includes an outer guide member having a distal end, a proximal hub, and a lumen extending therebetween. A radiofrequency perforation device includes a distal tip and a proximal portion. The radiofrequency perforation device is configured to translate within the lumen. The radiofrequency perforation device proximal portion includes a distal marker, an intermediate marker, and a proximal marker. Each of the distal marker, the intermediate marker, and the proximal marker are positioned and sized to provide an indication of the location of the distal tip of the radiofrequency perforation device in relationship to the distal end of the outer guide member.